NCT04665388

Brief Summary

This is a correlative research project aimed at characterizing the T cell mediated immune responses to hepatocellular carcinoma (HCC), as well as Epstein-Barr virus (EBV)- and human papillomavirus (HPV)-related cancers. This study will enroll approximately 105 patients over 48 months. Of these 105 patients, 30 are EBV-related cancer, 45 are HPV-related cancer, and 30 are HCC. Patients will have blood samples collected one time to identify cancer specific T cells and T cell receptors in their blood. They will also have tissue samples collected one time to study the different types of immune cells, especially the T cells and their receptors. The 105 patients enrolled in this study will be compared to retrospective samples (N=210; 30 from EBV-related cancer cohort, 180 from HPV-related cancer cohort).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2020Feb 2027

Study Start

First participant enrolled

November 30, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

6.2 years

First QC Date

December 3, 2020

Last Update Submit

June 5, 2026

Conditions

Solid Tumor

Keywords

Epstein-Barr Virus related cancerHuman Papilloma Virus related cancerHepatocellular Carcinomasolid tumor

Outcome Measures

Primary Outcomes (1)

  • Identifying the p-HLA epitopes across diverse HLA alleles

    To identify the p-HLA epitopes, we will examine a variety of clinically relevant tumor antigens, including alpha feto-protein (AFP) and carcinoembryonic antigen (CEA) in HCC, and canonical and cryptic protein antigens specific to the EBV-sequence and HPV-sequence open reading frames (ORFs).

    63 months

Secondary Outcomes (1)

  • Characterizing tumor-antigen specific TCR repertoire diversity across diverse HLA alleles, and further provide a comprehensive functional analysis that identifies immunodominant epitopes important for tumor control

    63 months

Study Arms (3)

EBV-related cancer cohort

up to N=30

HPV-related cancer cohort

up to N=45

HCC cohort

up to N=30

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Solid tumor patients, including patients with hepatocellular carcinoma (HCC) patients and Epstein-Barr virus (EBV)- human papillomaviruses (HPV)-related cancers.

You may qualify if:

  • Patients with a histological or cytological diagnosis of:
  • EBV-related malignancies (e.g. nasopharyngeal cancer)
  • HPV-related malignancies, including squamous cell carcinoma of the head and neck, cervix, vulva or anal canal. HPV positivity is required for squamous cell cancers of the head and neck.; p16 positivity as a surrogate for HPV testing is acceptable. HPV positivity is not required for cervix, vulva or anal canal cancer.
  • For cancers of the anal canal, late stage distant metastatic tumor tissue is preferred. However, early stage primary site tissue is acceptable, if the tissue can be procured without contamination by intestinal microbiota.
  • For HCC, only patients who have above UHN institutional upper limit of normal levels of alpha-fetoprotein (AFP) in serum will be eligible. The diagnosis of HCC should be made based on standard of care with or without tumor tissue confirmation.
  • Patients must be ≥ 18 years old.
  • Patients must have provided voluntary written informed consent.

You may not qualify if:

  • \. Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimens and interpretation of study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, tumor tissue

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Kathy Han, MD

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Han, MD

CONTACT

416-946-4501tip@uhn.ca

Kendra Ross

CONTACT

416-946-4501kendra.ross@uhn.ca

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 11, 2020

Study Start

November 30, 2020

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Locations

CA(1)